1. Area of the Art
The present invention relates generally to methods and systems for automated chemical analysis, and more specifically to automated immunochemistry instruments and methodologies.
2. Description of the Prior Art
Immunochemistry instruments are widely used in clinical chemistry sampling and analyzing applications for performing various assays. The following references are found to be pertinent to the field of the present invention:
U.S. Pat. No. 4,678,752, issued to Thorne, et al. on Jul. 7, 1987, disclosed an automated apparatus for analysis of samples. The apparatus includes an introduction station and a shuttle system work with reagent packages, each containing both sample receptacles and reagent receptacles.
U.S. Pat. No. 5,055,408, issued to Higo, et al. on Oct. 8, 1991, disclosed an automated enzyme-immunoassay analyzer. The analyzer is designed to work with test plates, each having a plurality of upwardly opened immunological reaction chambers and requires a test cup storage area located below a measuring part, and ascending and descending elevators respectively associated with the upstream and downstream ends of the transfer route of the measuring part and respectively connecting the upstream and downstream ends of the transfer route with the test cup storage area for respectively circulating test plates between the transfer route and the test cup storage area.
U.S. Pat. No. 5,158,895, issued to Ashihara, et al. on Oct. 27, 1992, disclosed an automatic immunoassay apparatus. The apparatus includes a plurality of reaction cartridges, each having at least two wells, including a first well of said at least two wells containing solid phase material carrying an antigen or an antibody and a second well of said at least two wells containing an antibody or an antigen labeled with labeling compound.
U.S. Pat. No. 5,380,487, issued to Choperena, et al. on Jan. 10, 1995, disclosed a device for processing materials. The device includes a first transport means adapted to transport articles along a first treatment path and a second transport means adapted to transport articles along a second treatment path. Both transporting means are elongated movable transporting means and include indexing positions.
U.S. Pat. No. 5,482,861, issued to Clark, et al. on Jan. 9, 1996, disclosed a method of operating an automated, continuous, and random access analytical system capable of simultaneously effecting multiple assays of a plurality of liquid samples. The method includes the step of preparing at least one unit dose disposable for each sample placed onto said system by (i) transferring an aliquot of the sample to a first well located in a reaction vessel having a plurality of separate and independent wells capable of receiving liquids; (ii) transferring to a second well located in the reaction vessel at least one reagent that is necessary for affecting the scheduled assay of the sample, such that reaction between the aliquot and the at least one reagent does not occur, the step of transferring the reaction vessel containing the at least one unit dose disposable to a processing workstation, and the step of transferring at least one of the aliquot of the liquid sample or the at least one reagent in a well in the reaction vessel to a well in the reaction vessel to combine the aliquot and the at least one reagent to form a reaction mixture necessary for performing one of the scheduled assays.
U.S. Pat. No. 5,501,838, issued to Ootani, et al. on Mar. 26, 1996, disclosed an automated immunochemical analyzer. The analyzer includes a table for mounting a reaction plate, wherein the table can be drawn out, and means for judging and displaying whether it is possible or impossible to draw out the table for mounting said at least one reaction plate.
U.S. Pat. No. 5,575,976, issued to Choperena, et al. on Nov. 19, 1996, disclosed an automated chemical analyzer. The analyzer includes an incubation station comprising an elongated, movable transport means adapted to carry a plurality of reaction vessels along an incubation path, and a wash station including a movable transport means adapted to receive and carry a plurality of reaction vessels along a wash-cycle path.
U.S. Pat. No. 5,580,524, issued to Forrest, et al. on Dec. 3, 1996, disclosed an automated multi-test capability assay apparatus in modular form for nonsequential processing of samples for assay. The apparatus includes a device for ensuring solid phase suspension which includes a housing, a rotatable support having means for independently rotatably mounting a vessel around a circumference of the support, and a drive wheel for rotating the mounted vessel, where the housing includes a driving surface having longer circumferential dimensions than the drive wheel and surrounding the drive wheel and engageable therewith.
U.S. Pat. No. 5,587,129, issued to Kurosaki, et al. on Dec. 24, 1996, disclosed an apparatus for automatically analyzing a specimen. The apparatus includes a first dispensing means for dispensing specimen in a sample vial into a stock vial, a second dispensing means for dispensing the specimen in the stock vial into an assay vial, and a third dispensing means for dispensing reagent into the assay vial.
U.S. Pat. No. 5,658,799, issued to Choperena, et al. on Aug. 19, 1997, disclosed a method for automatically analyzing a plurality of samples for at least two different analytes. The method includes the step of providing a transfer control means for controlling the transfer of reaction vessels from one assay resource station to another according to a chronology selected from a plurality of predetermined different chronologies, where the chronology for determining the analyte in the first sample being a different one of the predetermined different chronologies from the chronology for determining the analyte in the second sample.
U.S. Pat. No. 5,693,292, issued to Choperena, et al on Dec. 2, 1997, disclosed an automated chemical analyzer for automatically analyzing a plurality of samples for at least two different analytes. The analyzer includes an incubation station comprising an elongated, movable transport means adapted to carry a plurality of reaction vessels along an incubation path.
U.S. Pat. No. 5,846,491, issued to Choperena, et al on Dec. 8, 1998, disclosed an automated chemical analyzer for automatically analyzing a plurality of samples for at least two different analytes. The analyzer includes a transfer control means for controlling the transfer of reaction vessels directly from one assay resource station to another, according to a chronology selected from a plurality of different predetermined chronologies.
U.S. Pat. No. 5,856,193, issued to Fanning, et al. on Jan. 5, 1999, disclosed a method for conducting identification and susceptibility testing of a biological agent in a fluid sample in an automated sample testing machine. The method includes the steps of providing a sample holder that can receive a first receptacle containing a fluid sample, an identification test sample card that is fluid communication with the fluid sample contained in the first receptacle once placed on the sample holder, a second open receptacle, and a susceptibility test sample card that is in fluid communication with the second open receptacle once placed in the sample holder.
U.S. Pat. No. 5,885,529, issued to Babson, et al. on Mar. 23, 1999, disclosed an automated immunoassay analyzer. The analyzer includes dispensing means for receiving a plurality of inert support dispensing packs.
U.S. Pat. No. 5,885,530, issued to Babson, et al. on Mar. 23, 1999, disclosed an automated immunoassay analyzer. The analyzer includes an inert support supply and dispensing means for receiving a plurality of inert support dispensing packs each storing a single type of biomaterial-coated inert support.
While various automated immunochemistry analyzers and methods have been developed, as shown in the above references, there is a need for an automated immunochemistry analyzer that is capable of having a higher throughput, and also capable of being connected to other analyzers through a common sample handling unit, and further being capable of providing multiple pipetting modules that can work independently to ensure uninterrupted analysis, even when one of the modules malfunctions. Accordingly, it is desirable to provide a new method and system for automated immunochemistry analysis that can satisfy those needs.
The present invention is directed to a new method and system for an automated immunochemistry analysis.
It is one of the primary objects of the present invention to provide a new method and system for an automated immunochemistry analysis that is capable of having a higher throughput.
It is also a primary object of the present invention to provide a new method and system for an automated immunochemistry analysis that is capable of being connected to other analyzers through a common sample handling unit.
It is another one of the primary objects of the present invention to provide a new method and system for an automated immunochemistry analysis that is capable of providing and handling multiple pipetting modules which can work independently to ensure an uninterrupted analysis, even when one of the modules malfunctions.
In addition, it is a primary object of the present invention to provide a new method and system for an automated immunochemistry analysis that is capable of performing reflex testing with a large capacity chilled sample storage area.
It is also another one of the primary objects of the present invention to provide a new method and system for an automated immunochemistry analysis that incorporates a vessel loading apparatus that is capable of handling a bulk quantity of vessels.
It is still another one of the primary objects of the present invention to provide a new method and system for an automated immunochemistry analysis that incorporates a pick-and-place transporting device, which transports the vessels among various working areas of the system without dragging or jarring the vessels or splashing the contents of the vessels.
A. Summary of the Automated Immunochemistry Analyzer of the Present Invention
Described generally, the automated immunochemistry analyzer of the present invention includes the following basic components:
1. A sample aliquoting section having an operating cycle of a first period of time, and including a main sample pipetting station for aliquoting a desired amount of a sample from a sample container to a sample vessel (SV), wherein the quotient of the first period of time divided by the third period of time described below is a whole number;
2. A chilled storage for storing multiple sample vessels containing aliquoted samples;
3. A reagent pipetting section including multiple independent pipetting stations, each having an operating cycle of a second period of time, where the quotient of the second period of time divided by the third period of time is a whole number, the number of the multiple independent pipetting stations being equal to the whole number, and the respective cycles of such stations being staggered apart by the third period of time, such that at least one of the multiple independent pipetting stations is available for accepting at least one of the sample vessels containing an aliquoted sample at each operating cycle of the sample aliquoting section;
4. A reagent storage for storing multiple reagent packs, each containing at least one reagent;
5. The multiple independent pipetting stations, each having a pipettor for aspirating a required amount of sample from the at least one of the sample vessels containing an aliquoted sample and dispensing it into an reaction vessel (RV), and aspirating a required amount of reagent from the at least one of the reagent packs containing at least one reagent and dispensing it into the reaction vessel; and
6. An incubate-wash-read section having an operating cycle of a third period of time, to match the desired throughput of the instrument system.
B. Summary of the Automated Immunochemistry Analysis of the Present Invention
Described generally, the automated immunochemistry analysis of the present invention includes the following basic steps:
1. Providing a sample aliquoting section operating on a cycle of a first period of time, where the quotient of the first period of time divided by the third period of time described below is a whole number;
2. Providing a reagent pipetting section having a plurality of independent reagent pipetting stations each operating on a cycle of a second period of time, where the quotient of the second period of time divided by the third period of time is a whole number, and the number of the independent reagent pipetting stations being equal to the whole number;
3. Staggering apart respective cycles of the independent reagent pipetting stations by the third time period, such that at least one of the multiple independent pipetting stations is available for working with the sample aliquoting section at each operating cycle of the first period of time; and
4. Providing an incubate-wash-read section operating on a cycle of a third period of time, to match the desired throughput of the instrument system.
Such an arrangement has been found to provide a number of advantages. As explained in greater detail below, the new method and system for automated immunochemistry analysis of the present invention are capable of having a higher throughput, and also capable of being connected to other analyzers through a common sample handling unit, and further being capable of providing multiple pipetting modules that can work independently to ensure uninterrupted analysis, even when one of the modules malfunctions. In addition, the new method and system for automated immunochemistry analysis of the present invention are capable of performing reflex testing with a large capacity chilled sample storage area. Furthermore, the new method and system for automated immunochemistry analysis of the present invention have incorporated several novel and unique devices, including a sample presentation unit, a vessel loading apparatus that is capable of handling a bulk quantity of vessels, and a pick-and-place transporting device, which transports the vessels among various working areas of the system without dragging or jarring the vessels or splashing the contents of the vessels.
The system of the present invention may be used in connection with other chemical analyzer, such as, but not limited to, chemistry and hematology diagnostic instrumentation. Examples of such an instrumentation include Beckman Coulter Inc.""s Synchron Clinical Systems (Beckman Coulter Inc. Calif.).
The invention is defined in its fullest scope in the appended claims and is described below in its preferred embodiments.